Cytos Biotechnology reports results from phase IIa study with CYT003-QbG10 in patients suffering from atopic dermatitis

Cytos Biotechnology AG announced today results from a phase IIa study with CYT003-QbG10 in atopic dermatitis

ZURICH, Switzerland | July 3, 2007 |
Cytos Biotechnology AG (SWX:CYTN) announced today results from a phase IIa study with CYT003-QbG10 in atopic dermatitis. CYT003-QbG10 is an immunotherapeutic product candidate currently in development for the treatment of allergic diseases. The present study aimed to assess safety, tolerability and exploratory efficacy of the product candidate in a new indication, namely atopic dermatitis. The study was designed as a placebo-controlled, randomized and double-blind trial in 36 patients suffering from mild to moderate atopic dermatitis (AD). Exploratory efficacy was determined according to the Eczema Area and Severity Index (EASI), a commonly applied test to assess the extent and severity of AD.

Treatment with CYT003-QbG10 was safe and generally well tolerated. In both the placebo-treated and CYT003-QbG10-treated groups a similar reduction of the EASI scores was measured over the study period indicating no treatment effect for CYT003-QbG10 in atopic dermatitis at the dose level tested in this trial.

Dr. Wolfgang Renner, CEO of Cytos Biotechnology, commented: “While CYT003-QbG10 has shown strong efficacy in conjunction with a specific allergen in patients with house dust mite allergy, we are still in the process of identifying the best treatment parameters for its application as a monotherapy. This monotherapy has achieved first promising results in grass pollen and also house dust mite allergy. For the latter indication we are now testing higher doses of the product candidate. Based on the outcome of these studies we will then also consider the path forward in atopic dermatitis.”

About the phase IIa study
The randomized, double-blind and placebo-controlled phase IIa study included 36 male and female patients aged 18 to 65 and suffering from mild to moderate AD. Upon entry into the study, the extent and severity of the disease was assessed by the Eczema Area Severity Index (EASI), a commonly applied test for AD. The study participants were randomized into two treatment groups with 18 patients each and received 6 weekly subcutaneous injections of either 300 μg CYT003-QbG10 or placebo. Two weeks after the last dose, the disease status of the patients was again assessed by the EASI.

About allergic diseases and atopic dermatitis
Allergy as a whole is a multi-faceted disease and clinically manifests in various allergic disorders including allergic rhinitis, asthma, atopic dermatitis and food hypersensitivity. On the immunological level, so called T helper 2-type (Th2) immune responses are considered crucial for the initiation and maintenance of allergy. The prevalence of allergic diseases has dramatically increased over the last decades, especially in industrialized countries. It is estimated that today more than 20% of the world population suffers from allergic diseases1. AD is a certain type of eczema. It is a common chronic skin disease considered to be linked to an “allergic” Th2 type immune status of the patients. It most often begins in infancy and an estimated 20% of infants and young children experience disease symptoms. Roughly 60% of those continue to have AD also in adulthood2. Children with AD are at greater risk for developing other allergic diseases like rhinitis or asthma later in life. AD is characterized by a hypersensitivity reaction occurring in the skin that causes chronic inflammation and renders the skin dry, itchy and scaly. Irritants (e.g. wool, soap), allergens and emotional stress exacerbate disease symptoms and further trigger the overactive immune system. There is no cure available. Current medications such as immunomodulators, corticosteroids or antihistamines address disease symptoms only and may be associated with sideeffects, especially upon long-term use.

About CYT003-QbG10
CYT003-QbG10 is an immunotherapeutic product in development for the treatment of allergic diseases. It consists of the Immunodrug™ QbG10 which is comprised of the virus-like particle Qb filled with a synthetic immunostimulatory DNA sequence called G10. CYT003-QbG10 is designed as a disease-modifying treatment and aims to induce a potent Th1 type immune response in order to suppress an “allergic” Th2 type immune response. An open-label phase IIa study with CYT003-QbG10 combined with an allergen extract of house dust mites at a standard dose showed excellent longterm efficacy in patients allergic to dust mites. Furthermore, two placebo-controlled phase IIa studies with CYT003-QbG10 monotherapy delivered positive results in patients suffering from grass pollen and house dust mite allergy.

SOURCE: Cytos Biotechnology AG

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